GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification

NCT06722521 | Recruiting Phase 4 DMC

• 1 other identifier: 2025-0193
• Study Type: interventional
• Target: 7,435
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification

Conditions

Primary Prevention; Vascular Calcification

Keywords

Cardiovascular Diseases; Aspirin; Statin

Outcome Measures

Primary Outcomes (1)

• Event rate of a major adverse cardiovascular events

  Death from any cause, myocardial infarction, stroke, urgent coronary revascularization, resuscitated cardiac arrest, or unstable angina related hospitalization

  48months

Secondary Outcomes (11)

• Event rate of a all cause death

  48months

• Event rate of a cardiovascular death

  48months

• Event rate of a spontaneous myocardial infarction

  48months

• Event rate of a stroke

  48months

• Event rate of a urgent coronary revascularization

  48months

Study Arms (2)

Intensive lipid-lowering therapy without aspirin

EXPERIMENTAL

In this group, intensive lipid-lowering therapy is performed without aspirin using pitavastatin 4 mg/ezetimibe 10 mg, targeting patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease. ◦ Intervention Medications: Pitavastatin 4 mg/ezetimibe 10 mg (aspirin excluded)

Drug: Pitavastatin 4mg and ezetimibe 10mg, taken once daily

Statin Monotherapy with Aspirin

ACTIVE COMPARATOR

IIn this group, moderate-intensity lipid-lowering therapy is administered using pitavastatin 2 mg and aspirin for patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease. ◦ Intervention Medications: Pitavastatin 2 mg and aspirin (Based on the clinician's judgment, the statin dosage may be increased to pitavastatin 4 mg depending on the LDL response, and if there are adverse effects associated with aspirin, it can be replaced with clopidogrel.)

Drug: Pitavastatin 2 mg with aspirin 100 mg, taken once daily.

Interventions

Pitavastatin 4mg and ezetimibe 10mg, taken once daily DRUG

Intensive lipid-lowering therapy without aspirin

Intensive lipid-lowering therapy without aspirin

Pitavastatin 2 mg with aspirin 100 mg, taken once daily. DRUG

Moderate-intensity lipid-lowering therapy with aspirin

Statin Monotherapy with Aspirin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years and older
• Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)
• The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.
• The assessment of physiological significance must be performed within 6 months prior to randomization

You may not qualify if:

• Major ASCVD events (clinically documented ASCVD)
• If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible:
• Acute coronary syndrome (MI or unstable angina)
• Coronary revascularization (PCI, CABG) or other arterial revascularization
• Ischemic stroke (Not TIA)
• Symptomatic peripheral arterial disease (history of claudication with ABI \<0.90, or previous revascularization or amputation
• Patients with physiologically significant CAD
• Moderate to severe CAD (diameter stenosis \>50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography)
• Moderate to severe CAD (diameter stenosis \>50%) on CAG with positive fractional flow reserve (FFR) \< 0.8
• Patients with familial hypercholesterolemia.
• Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg/dL regardless taking a statin or not.
• Continuation of PCSK9 inhibitor is required during the clinical trial
• Patients with chronic kidney disease (\<eGFR 30mL/min/1.73m2)
• Advanced liver disease (Child-Pugh B or C)
• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 5 times upper limit of normal).

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Vascular Calcification; Cardiovascular Diseases

Interventions

pitavastatin; Ezetimibe; Aspirin

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Seung-Whan Lee

CONTACT

82230103170; seungwlee@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

KR (1)